BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 8815547 · Received July 23, 2019

    Report

    Report Number
    3005975625-2019-00015
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 30, 2019
    Report Date
    July 3, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFORMATION AND THE PHOTOS, THE CASE IS LIKELY TO BE A VASCULAR COMPROMISE. VASCULAR COMPLICATIONS (OCCLUSIONS) ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS AS PART OF HYALURONIC ACID-BASED DERMAL FILLERS INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE OR CLOSE TO A BLOOD VESSEL LEADING TO AN OCCLUSION OR A COMPRESSION AND BLOCKING THE BLOOD FLOW, GENERALLY REFERED TO AS VASCULAR COMPLICATION. IF THE VASCULAR COMPLICATION IS NOT DETECTED/DIAGNOSED AND TREATED TIMELY, IT CAN LEAD TO A SKIN NECROSIS. THE RISK OF VASCULAR COMPLICATION AND SKIN NECROSIS ARE MENTIONED IN THE PRODUCT LABELLING. BIBLIOGRAPHY: DELORENZI C. COMPLICATIONS OF INJECTABLE FILLERS, PART 2: VASCULAR COMPLICATIONS. AESTHET SURG J. 2014; 34 (4):584-600. FUNT D, PAVICIC T. DERMAL FILLERS IN AESTHETICS: AN OVERVIEW OF ADVERSE EVENTS AND TREATMENT APPROACHES. CLIN COSMET INVESTIG DERMATOL 2013; 6: 295-316. MANAFI A, BARIKBIN B, MANAFI A, HAMEDI ZS, MOGHADAM SA. NASAL ALAR NECROSIS FOLLOWING HYALURONIC ACID INJECTION INTO NASOLABIAL FOLDS: A CASE REPORT. WORLD JOURNAL OF PLASTIC SURGERY. 2015; 4 (1). HONG, J.Y., ET AL., IMPENDING SKIN NECROSIS AFTER DERMAL FILLER INJECTION: A "GOLDEN TIME" FOR FIRST-AID INTERVENTION. DERMATOL THER, 2017. 30 (2). MARUYAMA, S., A HISTOPATHOLOGIC DIAGNOSIS OF VASCULAR OCCLUSION AFTER INJECTION OF HYALURONIC ACID FILLER: FINDINGS OF INTRAVASCULAR FOREIGN BODY AND SKIN NECROSIS. AESTHET SURG J, 2017. 37 (9): NP102-NP108. SALVAL, A., ET AL., IMPENDING FACIAL SKIN NECROSIS AND OCULAR INVOLVEMENT AFTER DERMAL FILLER INJECTION: A CASE REPORT. AESTHETIC PLAST SURG, 2017. 41 (5): 198-1201. WANG, Q., ET AL., VASCULAR COMPLICATIONS AFTER CHIN AUGMENTATION USING HYALURONIC ACID. AESTHETIC PLAST SURG, 2018. 42 (2): 553-559.

    Description of Event or Problem · 1

    THIS EVENT HAPPENED OUTSIDE OF THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION,DURING THE TREATMENT OF THE LEFT INNER LIP, THE INJECTOR OBSERVED A CUTANEOUS WHITE FLASH AND AN IMMEDIATE FORMATION OF A WHITE STRIA (FROM LIP TO NOSE AND FROM LIP TO CHEEK). SHE IMMEDIATELY STOPPED TO INJECT AND INJECTED 1800 I.U OF HYALURONIDASE, INTRAVENOUS 1.5 ML BENTELAN, 5 BENTELAN 0.5 MG TABLETS (DISSOLVED BETWEEN TEETH AND GUMS) AND WARM COMPRESS. SHE PRESCRIBED TO THE PATIENT TO TAKE MACLADIN (CLARITHROMYCIN) TWICE A DAY FOR 7 DAYS. THE PATIENT WAS MONITORED EVERY DAY: ON (B)(6) 2019 THE INJECTOR INJECTED 300 I.U OF HYALURONIDASE IN THE WHOLE BLEACHED AREA, INTRAVENOUS 1.5 ML BENTELAN AND LASIX (1 VIAL BEFORE HYALURONIDASE INJECTION) ON (B)(6) 2019 THE INJECTOR INJECTED 250 I.U OF HYALURONIDASE IN THE WHOLE BLEACHED AREA AND PRESCRIBED 5 BENTELAN 0.5 MG TABLETS. 3 DAYS AFTER THE INJECTION (ON (B)(6) 2019) THE PATIENT COMPLAINTS SORE GUMS, MILD PAIN IN THE TIP OF THE NOSE (COLUMELLA) AND LEFT SWOLLEN NOSTRIL. THE INJECTOR INJECTED 200 I.U OF HYALURONIDASE IN THE INDURATION AND IN THE PAINFUL AREAS. ON (B)(6) 2019 THE INJECTOR INJECTED 100 I.U OF HYALURONIDASE IN THE INDURATION AND IN THE PAINFUL AREAS. HE ALSO PRESCRIBED 5 BENTELAN 0.5 MG TABLETS AND RECOMMENDED THE USE OF ARNICA CREAM COMBINED WITH LIPOGEL AND EMOLLIENT. A MEDICAL EXPERT WAS CONTACTED ON (B)(6) 2019 IN ORDER TO ASSIST THE PRACTITIONER REGARDING THE RESOLUTION OF THE ADVERSE EVENT. HE CONFIRMED THE VASCULAR COMPROMISE AND ADVISED THE CONTROL OF THE NECROSIS AS WE WERE AT DAY 3 AND: TO STOP INJECTING HYALURONIDASE (THE AMOUNT INJECTED WAS ADEQUATE); NO ANTIBIOTIC NEEDED; TO FOLLOW THE SITUATION VISITING THE PATIENT EVERY 2-3 DAYS; THE APPLICATION OF AN ANTIBIOTIC CREAM (FUCIDIN H CREAM, WITH FUSIDIC ACID AND HYDROCORTISONE ACETATE) THREE TIMES A DAY, FOR TEN DAYS. ON (B)(6) 2019 THE RESOLUTION OF THE SYMPTOMS WAS ONGOING AND ON (B)(6) 2019, THE PROBLEM SEEMED COMPLETELY SOLVED EVEN THOUGH MONITORING OF THE PATIENT WOULD BE ONGOING FOR ONE MONTH ACCORDING TO THE MEDICAL EXPERT ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612639 TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TPUL-183511B

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other